FDA Approves Amgen's Heart-Failure Drug Corlanor

By Lisa Beilfuss 

The U.S. Food and Drug Administration on Wednesday approved Amgen Inc.'s heart-failure treatment Corlanor, which had been designated for priority review in August.

The drug is an oral medication intended to regulate heart rate and reduce the risk of hospitalization for worsening heart failure in patients with stable, chronic heart failure caused by a poorly contracting lower-left part of the heart.

Amgen said Corlanor is the first new chronic heart-failure medicine approved by the FDA in nearly a decade.

According to the company, heart failure costs an estimated $31 billion in the U.S. each year, with the majority of the cost related to hospitalizations. The condition affects approximately 5.7 million people in the U.S., about half of whom have reduced left ventricular function, the FDA noted in a statement.

The FDA granted fast-track status for the drug last April and then assigned the priority review designation about four months later. Priority review is granted to drugs intended to treat serious conditions that, if approved, would demonstrate significant improvements in the safety or effectiveness of treatment, diagnosis or prevention when compared with standard applications.

The European Medicines Agency approved the drug in 2005 to treat stable angina and then approved in 2012 to treat chronic heart failure.

Amgen shares rose 1.3% to $167.63 in after-hours trading, adding to the 4% year-to-date gain through Wednesday's close.

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